BC Week In Review | Feb 15, 2019
Clinical News

Complete response letter for Motif's antibiotic

FDA issued a complete response letter to an NDA for iclaprim (MTF-100) from Motif Bio plc (LSE:MTFB; NASDAQ:MTFB) to treat acute bacterial skin and skin structure infections (ABSSSIs). Motif said FDA indicated additional liver toxicity...
BioCentury | Jan 17, 2019
Regulation

Products on shutdown standby

Products on shutdown standby On Jan. 14, FDA said it has reserves to continue drug reviews for five more weeks if the government shutdown continues. There are at least six PDUFA dates for new products...
BioCentury | Jan 5, 2019
Finance

Ready to launch

  The proposed $74 billion takeout of Celgene Corp. by Bristol-Myers Squibb Co. will not shift buysider attention away from upcoming and maturing drug launches heading into 2019, with plenty to track following a record...
BC Week In Review | Aug 17, 2018
Clinical News

Motif's antibiotic gets Priority Review

Motif Bio plc (LSE:MTFB; NASDAQ:MTFB) said FDA accepted and granted Priority Review to an NDA for iclaprim (MTF-100) to treat acute bacterial skin and skin structure infections (ABSSSIs). Its PDUFA date is Feb. 13, 2019....
BC Extra | Aug 14, 2018
Company News

Motif's antibiotic gets Priority Review

Motif Bio plc (LSE:MTFB; NASDAQ:MTFB) said FDA accepted and granted Priority Review to an NDA for iclaprim (MTF-100) to treat acute bacterial skin and skin structure infections (ABSSSIs). Its PDUFA date is Feb. 13, 2019....
BioCentury | Apr 6, 2018
Finance

Smid-cap smorgasbord

While the biggest milestone of the second quarter came early and turned out to be a disappointment, investors still have plenty to look forward to in immuno-oncology. In addition, specialist investors’ current strategy of overweighting...
BC Week In Review | Mar 23, 2018
Clinical News

Motif delays NDA for iclaprim in ABSSSIs

Motif Bio plc (LSE:MTFB; NASDAQ:MTFB) said it will delay submitting its NDA for iclaprim (MTF-100) to FDA until next quarter. The company had hoped to submit the NDA this quarter seeking the antibiotic's approval to...
BC Extra | Mar 20, 2018
Company News

Motif delays NDA for iclaprim in ABSSSIs

Motif Bio plc (LSE:MTFB; NASDAQ:MTFB) said it will delay submitting its NDA for iclaprim (MTF-100) to FDA until next quarter. The company had hoped to submit the NDA this quarter seeking the antibiotic's approval to...
BioCentury | Jan 6, 2018
Finance

Burgeoning bellwethers

  The miserable performance of large cap biotechs last quarter is likely to be a boon for small- and mid-cap players this year, in more ways than one. Buysiders spent most of 2017 focusing to...
BC Week In Review | Oct 6, 2017
Clinical News

Motif's iclaprim meets in second Phase III for ABSSSIs

Motif Bio plc (LSE:MTFB; NASDAQ:MTFB) reported top-line data showing that iclaprim (MTF-100) met the primary endpoint of non-inferiority to vancomycin in the Phase III REVIVE-2 trial to treat acute bacterial skin and skin structure infections...
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BC Week In Review | Feb 15, 2019
Clinical News

Complete response letter for Motif's antibiotic

FDA issued a complete response letter to an NDA for iclaprim (MTF-100) from Motif Bio plc (LSE:MTFB; NASDAQ:MTFB) to treat acute bacterial skin and skin structure infections (ABSSSIs). Motif said FDA indicated additional liver toxicity...
BioCentury | Jan 17, 2019
Regulation

Products on shutdown standby

Products on shutdown standby On Jan. 14, FDA said it has reserves to continue drug reviews for five more weeks if the government shutdown continues. There are at least six PDUFA dates for new products...
BioCentury | Jan 5, 2019
Finance

Ready to launch

  The proposed $74 billion takeout of Celgene Corp. by Bristol-Myers Squibb Co. will not shift buysider attention away from upcoming and maturing drug launches heading into 2019, with plenty to track following a record...
BC Week In Review | Aug 17, 2018
Clinical News

Motif's antibiotic gets Priority Review

Motif Bio plc (LSE:MTFB; NASDAQ:MTFB) said FDA accepted and granted Priority Review to an NDA for iclaprim (MTF-100) to treat acute bacterial skin and skin structure infections (ABSSSIs). Its PDUFA date is Feb. 13, 2019....
BC Extra | Aug 14, 2018
Company News

Motif's antibiotic gets Priority Review

Motif Bio plc (LSE:MTFB; NASDAQ:MTFB) said FDA accepted and granted Priority Review to an NDA for iclaprim (MTF-100) to treat acute bacterial skin and skin structure infections (ABSSSIs). Its PDUFA date is Feb. 13, 2019....
BioCentury | Apr 6, 2018
Finance

Smid-cap smorgasbord

While the biggest milestone of the second quarter came early and turned out to be a disappointment, investors still have plenty to look forward to in immuno-oncology. In addition, specialist investors’ current strategy of overweighting...
BC Week In Review | Mar 23, 2018
Clinical News

Motif delays NDA for iclaprim in ABSSSIs

Motif Bio plc (LSE:MTFB; NASDAQ:MTFB) said it will delay submitting its NDA for iclaprim (MTF-100) to FDA until next quarter. The company had hoped to submit the NDA this quarter seeking the antibiotic's approval to...
BC Extra | Mar 20, 2018
Company News

Motif delays NDA for iclaprim in ABSSSIs

Motif Bio plc (LSE:MTFB; NASDAQ:MTFB) said it will delay submitting its NDA for iclaprim (MTF-100) to FDA until next quarter. The company had hoped to submit the NDA this quarter seeking the antibiotic's approval to...
BioCentury | Jan 6, 2018
Finance

Burgeoning bellwethers

  The miserable performance of large cap biotechs last quarter is likely to be a boon for small- and mid-cap players this year, in more ways than one. Buysiders spent most of 2017 focusing to...
BC Week In Review | Oct 6, 2017
Clinical News

Motif's iclaprim meets in second Phase III for ABSSSIs

Motif Bio plc (LSE:MTFB; NASDAQ:MTFB) reported top-line data showing that iclaprim (MTF-100) met the primary endpoint of non-inferiority to vancomycin in the Phase III REVIVE-2 trial to treat acute bacterial skin and skin structure infections...
Items per page:
1 - 10 of 32